NDA
NDA. Means Blake's New Drug Application for the Product, as such application type is defined in the United States Federal Food, Drug and Cosmetic Act, and applicable regulations promulgated thereunder, as amended from time to time.
NDA. A New Drug Application filed with the FDA in accordance with Applicable Law
NDA. Means a New Drug Application, Abbreviated New Drug Application, Biologics License Application, or similar application which is required to be filed with the FDA to obtain a marketing approval of a Product in the United States
Found in
Repligen Corporation contract
NDA. Means a New Drug Application as described in 21 C.F.R. Part 314, filed with the FDA after completion of clinical trials to obtain Approval for a Licensed Product in the United States.
Found in
IONIS PHARMACEUTICALS INC contract
NDA. Defined in the Commercial License Agreement
Found in
Sage Therapeutics, Inc. contract
NDA. Means the New Drug Application and similar regulatory approvals filed with the FDA or other agencies for the applicable Product, and any amendments or Supplemental New Drug Applications thereto, or documents incorporated by reference.
NDA. Shall mean a new drug application or product license application or its equivalent filed after completion of human clinical trials to obtain marketing approval for a Licensed Product in any country.
NDA. A New Drug Application filed pursuant to the requirements of the FDA, a Biologics License Application filed pursuant to the requirements of the FDA, and any equivalent application filed in any country outside of the Territory, together, in each case, with all additions, deletions, or supplements thereto.
Found in
MARINUS PHARMACEUTICALS INC contract
NDA. Shall mean New Drug Application to be filed with the FDA by CLARUS for the Marketing Authorization for the Finished Product.
Found in
CLARUS THERAPEUTICS INC contract
NDA. The Mutual Non-Disclosure Agreement, dated August __, 2013, entered into by and among Cytori, and Lorem.
All Definitions
Found in
CYTORI THERAPEUTICS, INC. contract